Swelling of solid dosage forms such as tablets (regular, film- or sugar-coated) and capsules (soft and hard), represent a problem causing difficult in ingestion for a significant portion of the adult population (about 30%). The incidence of these difficulties significantly increases in children and teenagers and in the elderly population in view of difficulty in ingestion.
Oral suspensions could solve the administration problem but present some drawbacks due to the weight of the container, usually consisting of glass and subsequent lack of comfort, e.g. when the patient travels.
For this reason, solid formulations which readily dissolve when administered are preferred.
Unfortunately not all active components can be formulated in oral disintegrating tablet (ODT) form, because of taste or stability problems.
In particular, when ODT dissolves into the oral cavity, the concentration of drug in the saliva is very high, due to the reduced volume of saliva (0.5-1.0 ml) causing taste problems.
Meloxicam, a known non steroidal anti-inflammatory drug (NSAID), is marketed by Boehringer-Ingelheim in the form of tablets, oral suspensions and suppositories.
Meloxicam, as most drugs belonging to the category of oxicams such as ampiroxicam, droxicam and piroxicam, is characterized by a bitter taste making difficult its buccal administration in form of oral disintegrating tablet.
CN1546033 (Chengu Shengnuo Sci. & Technology Dev. Co.) discloses ODT of meloxicam containing lactose, mannitol, crystalline cellulose, low substituted methyl-cellulose, propylene glycol ether, cross bonding polyvinylpyrrolidone, sodium hydrogen carbonate, citric acid, aspartame, perfume and magnesium stearate.
WO 2005/117895 (Boehringer Ingelheim) discloses solid dosage forms containing meloxicam in combination with another active ingredient in admixture with a pharmaceutically acceptable carrier.
WO 99/09988 (Hexal AG) discloses solid dosage forms of meloxicam with improved solubility and bioavailability.